US Pesticide Regulations

In the US, Steptoe advises and represents clients in all aspects of how conventional, antimicrobial, biochemical, and microbial pesticides and plant-incorporated protectants are regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Federal Food, Drug, and Cosmetic Act (FFDCA), and applicable state pesticide control laws.

During research and development (R&D), we advise clients about R&D permit requirements and available permit exemptions, how to import pesticides and candidate substances into and export them from the US for R&D, how to package and label R&D pesticides for distribution in the US, how to protect the confidential chemical identities of R&D pesticides, and when and how to report R&D study results to the US Environmental Protection Agency (EPA) and state agencies.

When clients are ready to commercialize a product, we help them to register new pesticidal active ingredients, new products containing existing active ingredients, and new uses of existing products. We also help clients to identify applicable registration data requirements, including products performance (efficacy) requirements, and how to satisfy data requirements for different product types, use patterns, and use sites and for use against specific pests. When clients prefer a state-specific registration to a national one, we help them to obtain a special local needs registration under section 24(c) of FIFRA.

For pesticides that will have agricultural or food-contact uses and that need but lack tolerances (maximum residue levels) for post-application residues of the product's ingredients, we help clients to apply for and obtain the needed tolerances, or we help them to obtain an exemption from the requirement for a tolerance. For antimicrobial pesticides that also are regulated by the US Food and Drug Administration (FDA) as food additives, we advise clients about their additional requirements under the FFDCA and how to coordinate the separate regulatory activities of EPA and FDA.

For clients who develop FIFRA registration data on their own, we help to place and supervise studies, and we advise clients how to protect their data against unlicensed and uncompensated use by follow-on applicants. For clients who seek to develop data with others, we establish joint data development task forces (consortia), prepare the task force agreements, and either provide or place any needed task force support. For clients who seek to cite and rely upon others’ registration data, we represent clients in licensing and data compensation negotiations with data owners.

We advise clients regarding product label development and amendment, including the product performance and other claims that clients may lawfully make on their labels, in other labeling, and in media other than labels and labeling, for example, in or on company, distributor, or ecommerce websites, social media platforms, print advertising, radio, television, trade show materials, and other promotional materials.

Before clients have registrations, we advise them how to import, sell, distribute, and export unregistered pesticides under and in compliance with available registration exemptions. If clients need an emergency exemption under section 18 of FIFRA, we help them to obtain the exemption.

When clients have registrations, we advise them how to import, sell, distribute, and export products in compliance with all applicable requirements, including for import notification, packaging, labeling, chemical composition, claims made as part of distribution or sale, and export reporting. In California, we advise clients how to report their quarterly sales of registered pesticides into California and how to pay the associated mill assessment to California’s Department of Pesticide Regulation.

For clients who will produce their own pesticides, we help them to register their producing establishments (in and outside of the US) and to comply with annual establishment reporting requirements. For clients who will license their registered pesticides for sale and distribution by others, or who will seek to be a licensee of a registrant, we advise clients how to comply with the applicable requirements for supplemental distribution under FIFRA, and we prepare and review supplemental distribution agreements.

After registration, we advise clients about post-registration requirements, including when and how to report any adverse effects information to EPA under section 6(a)(2) of FIFRA (and to state agencies under equivalent state laws), how to respond to data call-in notices issued by EPA, and how to comply with periodic registration review requirement for registered products under section 3(g) of FIFRA, including any Endangered Species Act requirements that may apply to specific uses of individual pesticides.

Lastly, we represent clients with respect to information requests, desk audits, in-person inspections, Notices of Refusal of Admission (for imports), Stop Sale, Use, and Removal Orders, and other enforcement actions by EPA and state agencies, and we conduct specialized due diligence in corporate transactions in which the purchase or sale of pesticide products is an important issue.